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Erythromycin 250mg Gastro-Resistant Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER_

ERYTHROMYCIN 250mg GASTRO-_RESISTANT TABLETS_

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Erythromycin Tablets are and what they are used for

2.    What you need to know before you take Erythromycin Tablets

3.    How to use Erythromycin Tablets

4.    Possible side effects

5.    How to store Erythromycin Tablets

6.    Contents of the pack and other information

1. What Erythromycin Tablets are and what they are used for

The name of your medicine is Erythromycin 250mg gastro-resistant tablets and it contains erythromycin which belongs to a group of medicines called macrolide antibiotics.

This medicine is used to prevent and treat infections such as:

•    Throat and sinus infections

•    Chest infections, such as bronchitis and pneumonia

•    Ear infections

•    Mouth and dental infections

•    Eye infections

•    Skin and tissue infections, such as acne

•    Stomach and intestinal infections

•    Prevention of infection following burns, operations or dental procedures

•    Other infections, such as sexually transmitted diseases, bone infections or scarlet fever

2. What you need to know before you take Erythromycin Tablets Do not take this medicine if you :

   have ever been told you are allergic to erythromycin, or other macrolide antibiotics such as clarithromycin or azithromycin, sunset yellow FCF (E110), ponceau 4R red


(E124) or any of the other ingredients (listed in section 6)

•    are currently taking a medicine called

-    ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects.

-    terfenadine or astemizole (widely taken for hayfever and allergies), cisapride (for stomach disorders) or pimozide (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead.

•    are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects.

Take special care with Erythromycin Tablets

Talk to your doctor or pharmacist before taking Erythromycin tablets

if you:

•    have impaired renal function

•    have any liver problems or have been told that any drugs you are taking can cause liver problems

•    have previously experienced diarrhoea following the use of antibiotics

•    are pregnant and have been told that your have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your body. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and child is under 1 year and is prescribed erythromycin, consult your doctor before giving erythromycin to your child.

•    are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.

•    suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin.

•    are taking erythromycin with ‘statins' such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur.

If any of these apply to you, or if you are not sure, tell your doctor.

Effect on urine test

If you are having urine test, let the doctor or nurse know that you are taking erythromycin. This is because erythromycin can affect the results of these tests.

Other medicines and Erythromycin Tablets

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicine


This is especially important if you are taking medicines from the following families:

•    astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever)

•    pimozide (used to treat mental problems)

•    ergotamine or dihydroergotamine (used to relieve migraine)

•    cisapride (used to treat stomach disorders)

•    statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin)

•    protease inhibitors (used to treat viral infections e.g. saquinavir) This is also important if you are taking medicines called:

•    colchicine (used to treat gout and arthritis)

•    cimetidine and omeprazole (used to treat acid reflux and other related conditions)

•    clarithromycin, rifabutin or rifampicin (medicines used to treat different types of bacterial infection)

•    fluconazole, ketoconazole and itraconazole (medicines used to treat fungal infections)

•    digoxin, quinidine or disopyramide (used to treat heart problems)

•    cilostazol (a medicine used to treat peripheral circulation problems)

•    hexabarbitone, phenobarbital or midazolam (used as sedatives)

•    warfarin and acenocoumarol (used to help thining the blood)

•    valproate, carbamazepine or phenytoin (used to control epilepsy)

•    theophylline (used to treat asthma and other breathing problems)

•    ciclosporin or tacrolimus (used following organ transplants)

•    bromocriptine (used to treat Parkinson's disease)

•    zopiclone or triazolam/alprozolam (used to help you sleep or relieve states of anxiety)

•    alfentanil (a medicine used to provide pain relief)

•    methylprednisolone (used to help suppress the body's immune system this is useful in treating a wide range of conditions)

•    St John's Wort (a herbal medicine used to treat depression)

•    verapamil (used to treat high blood pressure and chest pain)

•    vinblastine (used to treat certain types of cancer)

•    sildenafil (used to treat erectile dysfunction)

If you or your child goes for any medical tests, tell your doctor that you are taking this medicine, as this may interfere with some test results.

Pregnancy, breast-feeding and fertility

•    Erythromycin should be used by women during pregnancy only if clearly needed.

|


Erythromycin Tablets INSERT

SAME SIZE ARTWORK 240 x 160 mm Front


240 mm


•    If you are pregnant or think you may be pregnant, or if you are breast feeding, please consult your doctor before taking this medicine.

Erythromycin Tablets contain

Sunset yellow FCF (E110) and ponceau 4R red (E124) which may cause allergic reactions.

|    3. How to use Erythromycin Tablets    |

•    Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.

•    The dosage and duration of treatment will depend on the type and severity of the infection.

•    Swallow the tablets whole with a glass of water.

The usual dose of Erythromycin 250mg Gastro-resistant tablets for adults and children over 8 years is:

1-2g daily in divided doses i. e. four to eight 250mg tablets daily taken just before or with meals or food. If you have a bad infection you may be told to take up to 4g daily.

If you take more Erythromycin tablets than you should:

Tell your doctor immediately or contact your nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. An overdose of these tablets could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythromycin tablets If you forget to take a dose, take it as soon as remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Erythromycin tablets Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

|    4. Possible Side Effects    |

Like all medicines, Erythromycin may sometimes cause side effects, although not everybody gets them.

If you notice any of the following, contact your doctor immediately:

•    difficulty breathing

•    fainting

•    swelling of the face, lips or throat

•    skin rashes


•    severe skin reactions including large fluid-filled blisters, sores and ulcers

•    ulcers in the mouth and throat as these may be signs of an allergic reaction.

Other side effects include:

•    diarrhoea which may be severe or prolonged and may contain blood or mucus

•    feeling sick or being sick

•    increase in a particular type of white blood cells (eosinophilia)

•    stomach pains; these may be a symptom of an inflamed pancreas (pancreatitis)

•    ringing in the ears (tinnitus)

•    reversible loss of hearing (usually associated with high doses in patients with kidney problems)

•    various liver or gall- bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine

•    chest pains

•    abnormal heart rhythms (including palpitations)

•    fever

•    anorexia

•    confusion

•    fits (seizures)

•    vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly on standing)

•    hallucinations (seeing or hearing things that aren't there)

•    feeling generally unwell (malaise)

•    inflammation of the kidneys ( a condition known as interstitial nephritis)

•    low blood pressure

•    serious skin rashes that may involve blistering and can cover large areas of the torso, face and limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Erythromycin Tablets

•    Keep out of the sight and reach of children.

•    Do not use these tablets after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of the month.


•    Securitainers and Polybags: Store below 250C. Store in the original package to protect from moisture and light. Keep the container tightly closed.

Blister Packs: Store below 250C. Store in the original package to protect from moisture and light.

•    Do not throw any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Erythromycin tablets contain:

•    The active ingredient is Erythromycin.

•    The other ingredients are - Maize Starch, Croscarmellose Sodium Type A, Povidone (Kollidon K90), Talc, Magnesium Stearate (E572),

Sub coat: Hydroxypropylmethylcellulose (E464), Macrogol 6000, Sunset yellow FcF (E110), Ponceau 4R red (E124) Enteric coat: Methacrylic Acid Copolymer, Macrogol 6000, Talc, Polysorbate 80 (E433),Sunset yellow FCF (E110), ponceau 4R red (E124)

What Erythromycin tablets look like and contents of the pack:

•    Reddish orange coated, circular tablets plain on one side and embossed with ‘250' on the other.

•    Erythromycin Tablets are available in Securitainers packs of 21, 100, 250, 500 and 1000 tablets and Blister packs of 28, 56, 84 and 100 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and    address:    Bristol Laboratories Limited

Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG, United Kingdom Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Erythromycin 250mg gastro-resistant tablets; PL 17907/0005 This leaflet was last revised in May 2015 To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.


V13 26-05-15 D0


160 mm


SAME SIZE ARTWORK

240 x 160 mm

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240 mm